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Qlaira® – innovative estradiol-based oral contraceptive available in Europe from May onwards


WEBWIRE

A new oral contraceptive delivering the same estrogen as produced by the female body

Berlin – Bayer Schering Pharma AG, Germany, is starting the European roll-out of its new oral contraceptive Qlaira® (estradiol valerate/dienogest). From May 15, 2009, Qlaira® will be available in several European countries, including Germany. More European countries will follow from autumn 2009 onwards.

Qlaira is the first in a new class of oral contraceptives to deliver estradiol, the estrogen identical to the one produced by the female body. Over the past 50 years, many new progestins have been developed for use in oral contraceptives, but the estrogen component remained the same – ethinylestradiol. The introduction of Qlaira thus offers women a new choice in oral contraception.

“We are highly delighted that we will now bring Qlaira – our latest innovation in the field of contraception – to women all over Europe,” said Phil Smits, M.D., Head of Women’s Healthcare at Bayer Schering Pharma. “As worldwide market leader in women’s healthcare and a company leading in research, we are committed to developing new products and improving on the existing range in order to better serve women and their contraceptive needs.”

Qlaira contains the combination of estradiol valerate – which is immediately metabolized to estradiol, the same estrogen as produced by a woman’s ovaries – with the progestin dienogest in a unique dynamic dosing regimen. This dosing regimen has been designed to deliver hormones at the right levels at the right time during the cycle to provide reliable contraception and good cycle control.

Until now, efforts to use estradiol in oral contraception have failed to achieve a satisfactory level of bleeding control. Clinical studies with Qlaira however have shown that the new combination’s cycle control is as good as that of oral contraceptives containing 20 µg of ethinylestradiol.

Bayer Schering Pharma is also developing Qlaira for the treatment of heavy and/or prolonged menstrual bleeding in women without organic pathology who desire oral contraception. An approval for this additional indication would represent another important milestone; no other contraceptive has yet been approved for treating this condition.

About Bayer
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials.

Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care divisions.

Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.


About Bayer Schering Pharma
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women’s Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.


Forward-looking statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.



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